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Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card
Recalled May 9, 2018 · FDA recall Z-1542-2018 · Ameditech
Hazard
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box. · FDA Class III
Units
828 kits (20,700 devices)
Sold at
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Description
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Product
Alere iScreen Dx Urine Drug Screen Card
Manufacturer(s)
Ameditech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →